Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2013 Dec;4(Suppl 1):S20-8.
doi: 10.4103/0976-500X.120942.

Pharmacovigilance in Italy: An overview

Carmela Mazzitello  1 , Stefania Esposito  1 , Adele E De Francesco  2 , Annalisa Capuano  3 , Emilio Russo  1 , Giovambattista De Sarro  1
Affiliations
Review

Pharmacovigilance in Italy: An overview

Carmela Mazzitello et al. J Pharmacol Pharmacother. 2013 Dec.

Abstract

Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy.

Materials and methods: The information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA).

Results: The pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010) and the Directive (2010/84/EU) aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs.

Conclusion: A greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting.

Keywords: ADRs; AIFA; Italian; legislation; monitoring.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: Nil.

Figures

Form 1
Form 1
ADR Reporting Form
See this image and copyright information in PMC

References

    1. A guide to detecting and reporting adverse drug reactions. Geneva, Switzerland: World Health Organization; 2002. World Health Organization. Safety of medicines.
    1. White T, Arakelian A, Rho JP. Counting the cost of drug-related adverse events. Pharmacoeconomics. 1999;15:445–58. - PubMed
    1. Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol. 2005;60:653–8. - PMC - PubMed
    1. Rawlins MD. Spontaneous reporting of adverse drug reactions. I: The date. Br J Clin Pharmacol. 1988;26:1–5. - PMC - PubMed
    1. Morgan K, Morgan SN. 4th ed. Lawrence, Kansas: Morgan Quitno Press; 1996. Quito Health Care State Rankings 1996.

LinkOut - more resources